Customsurg AG
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000050675 FEI 3045751562
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Customsurg AG makes
Customsurg AG manufactures the CustomSurg OrthoPlanner, a surgical planning tool designed to assist in orthopedic procedures by providing pre-operative simulations and anatomical assessments.
The company’s portfolio is regulated under FDA’s Class II device category and is listed via the 510(k) clearance pathway. The manufacturer is based in the United States.
Catalogue
CustomSurg OrthoPlanner Ref ORTHO1
CE MDR EUDAMEDCustomSurg OrthoPlanner Ref K251863
510(k) 510(k)
Company details
- EUDAMED SRN
- CH-MF-000050675
- FDA FEI number
- 3045751562
- EUDAMED status
- Active
- EUDAMED registered name
- CustomSurg AG
- Registered address
- 1, Bubenbergstrasse, 8045, Zurich, Switzerland
- [email protected]
- PRRC contact
- Thomas Zumbrunn
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Jun 2031
Notified body 2443 1 certificate
- G11DK 136906 0002 Issued
Quality management system EU MDR
- Issued
- 11 Jun 2026
- Expires
- 10 Jun 2031
Frequently asked questions
How many devices does Customsurg AG have in the registry?
The registry currently lists 2 devices for Customsurg AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Customsurg AG's devices?
Among its 2 most recently registered devices, Customsurg AG has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Customsurg AG's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Customsurg AG's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Customsurg AG?
EUDAMED lists 1 certificate for Customsurg AG (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-06-11.
What are the newest devices from Customsurg AG in the registry?
The most recently registered devices listed for Customsurg AG include CustomSurg OrthoPlanner.